7.6 FOOD CONTAMINATION

The construction of and finish on all metal cookware and bakeware should permit easy cleaning of the vessel. There should be no crevices, seams or rough edges to harbor food or bacteria, particularly on food contact surfaces that cannot be readily cleaned.

7.7 APPLIED FINISHES/DECORATIONS TO METAL COOKWARE AND BAKEWARE

A finish or decoration for cookware can be any material which, when applied, changes the basic appearance and/or function of that cooking utensil from its natural surface.

The finish or decoration may be applied through the use of either organic or inorganic materials. It may be fused on under high heat, spray-applied and bake-dried, plated over the metal, applied by an electrolytic (anodized) method, or in some cases, silk screen or applied decal, as in the case of a decoration.

The type of finish or decoration has certain advantages in each instance, and, generally, its application will be made where factors of use, durability, heat, abrasion, design and appearance or other requirements will make one finish more suitable than another.

Any applied finish or decoration used on a utensil must be acceptable within all applicable federal and state regulations. This applies, but is not limited to, the following types of finishes or decorations:

The finishes or decorations, as outlined, are not intended to be all-inclusive, but they do represent those most commonly used on metal cookware products. There are other finishes under various individual company trade names, some of which are variations of finishes or decorations indicated in the above listing.

There are a number of rules and regulations that are applicable to the allowable limits of toxic metals that may be a part of materials of applied finishes/decorations as used on the food contact surfaces of cookware and bakeware.

7.7.1 Applied Finishes Intended to Come Into Contact with Food.

Applied cookware and bakeware finishes, including nonstick coatings, intended to come into contact with foods, must comply with laws, regulations, directives and/or recommendations of the countries in which they are marketed. Finishes in the U.S. are covered by Food and Drug Administration regulations that have the full force and effect of law. As nonstick coatings are a primary food contact finish, this section provides guidance for manufacturers wishing to use such nonstick finishes for food contact coatings in the U.S. and Europe.

7.7.1.1 U.S. Regulations
In the United States, nonstick coatings fall into two categories:

Those intended for use in commercial applications such as food-processing facilities, deli departments of grocery stores; and,

Those applied to noncommercial housewares for use in homes and restaurants to prepare, dispense and serve food.

Nonstick coatings intended for use in commercial applications must comply fully with the Federal Food, Drug and Cosmetic Act regulations found in Title 21 of the Code of Federal Regulations. 1 An applied nonstick coating will meet these criteria if:

the coating is applied in a continuous film over a metal or other suitable substrate;

the coating is formulated with approved substances generally recognized as safe, permitted by prior sanction or approval or specifically listed in 21 CFR;

extraction tests are conducted on the coating based upon the types of food and the conditions of use recognized by the FDA;

the coating passes extraction tests when tested with food-simulation solvents and under conditions of time and temperature that characterized the intended conditions of use;

the extractives are measured by employing the analytical methods required by the FDA;

the tests are conducted using equipment and reagents required by the FDA; and,

the coating has been thoroughly cleansed prior to its first use. It is each manufacturers responsibility to communicate this final requirement to the enduser via product literature or package instructions.

Nonstick coatings applied to noncommercial housewares for use in homes and restaurants to prepare, dispense, or serve foods are exempt from the FDA’s food additive regulation under what is commonly referred to as the “housewares exemption.” There is one exception: The FDA will take immediate action to protect the public’s health if the nonstick coating is found to adulterate food with unsafe substances.

Although housewares are not regulated, it is incumbent on the manufacturer to ensure that each coating is formulated with ingredients known to be safe for use in contact with food and that are appropriate for the intended conditions of use. The prudent manufacturer will have testing performed by a third party laboratory and/or obtain certification from their coatings suppliers, to ensure that the nonstick coatings comply with the same FDA test criteria as coatings used in commercial applications. Nonstick coatings produced under the housewares exemption and tested in accordance with the FDA criteria may be said to comply fully with the Food, Drug & Cosmetic Act and all applicable food additive regulations.Manufacturers should be aware that products may need to comply with other state, federal and international regulations, depending on where the products are to be marketed.

7.7.1.2 European Regulations

For food contacting surfaces, Europe has some 17 differing types of items. Some are well-regulated while others still have legislation awaiting formalization. Regulations are automatically law in EU countries while directives have to be approved by each country’s legislative body.

There is, as of yet, no harmonized legislation regulating the manufacture of nonstick coatings in Europe. Rather, food-contact materials used within the Member States of the European Union (EU) are governed by regulation 1935/2004/EEC. Although directives establish general principles for materials intended to come into contact with food, regulations can have more onerous requirements. All food-contact materials must be manufactured in accordance with good manufacturing practices and must not adulterate food, see regulation 2023/2006.

Many EU states have laws or “positive lists” of permissible substances. Others rely on recommendations, (e.g. for Germany BfR) or resolutions, (e.g. Council of Europe AP[96-5]). There are now 2004 versions of these listings and some old “89” versions are still valid. There is also a CEPE list. While not legally binding, many cookware manufacturers insist that coatings meet these recommendations and resolutions.

To facilitate trade, EU states have agreed to the principle of “mutual recognition”. This allows for the legal importation and sale of housewares produced in one member state which are legally marketed in another member state even if the products do not comply with the specific regulatory requirements of the country of import.

Manufacturers planning to market their products in Europe should inform their coating suppliers where the housewares will be offered for sale so that formulations are produced with compliant ingredients. Failure to do so may result in the introduction of illegal products into the European marketplace. Note that US FDA approval does not guarantee EU approval of a substance.

7.7.1.3 State Regulations

Nonstick coatings in both their liquid and finished (post-processing) form may be subject to other federal and state agency regulations that may be unrelated to their safe use with food. For example:

California. California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (known as Proposition 65) seeks to prevent certain chemicals causing cancer or reproductive toxicity from being discharged into water and from exposing individuals to these substances with out giving a “clear and reasonable warning” before “knowingly and intentionally” exposing anyone to a listed chemical. While not an officially adopted regulation, California’s Attorney General has used the following standard to enforce Proposition 65: California bans lead content greater than 0.1 parts per million in any foodware surface, as tested using the AOAC method, 15th edition, section 973.32. This method relies on Standard Method ASTM-C-738 for determining leached lead and cadmium, and is reproduced as exhibit “C” in this manual. Manufacturers should advise their coating suppliers that their products will be introduced into commerce in California to ensure that coatings formulae will comply with provisions of Proposition 65.

Minnesota Statute 115A.9651. This statute bans the intentional introduction or incidental presence above 100 parts per million of lead, cadmium, mercury or hexavalent chromium into any pigment, paint, dye, ink or fungicides used or sold in the state after 1998.

Massachusetts 105 CMR 460.200 Lead Poisoning and Control. This regulation makes illegal the acts of applying any lead-based paint, glaze or other substance to any toy, furniture, cooking, drinking or eating utensil and the sale, intent to sell, delivery or give away of items to which a lead based paint, glaze or other substance as been applied. “Lead based” means that when tested by ASTM Standard Method C 738, the results are greater than 2 ppm lead.

7.7.1.4 Additional Testing

FDA-mandated extraction studies do not test for heavy metals nor are they intended to do so. Manufacturers may want to have coating formulations independently tested or reviewed for a variety of reasons. Independent laboratories can use various techniques to ascertain trace amounts of or materials contained within coatings. Such independent tests can be used to determine if the coatings contain detectable amounts of heavy metals and/or that the coatings ingredients conform to FDA regulations. The FDA uses equal to or less than 0.5 ppb (parts per billion) dietary concentration as the level at which a substance is not considered a food additive. (See 21 CFR170.39).

Manufacturers relying on third party manufacturing sources, particularly those in developing countries, should be especially vigilant regarding coatings and should conduct independent testing and periodic retesting of applied coatings, including nonstick coatings, to ensure product quality.

For glazed ceramic surfaces on non-metal cookware and for enamelware finishes on metal cookware only, the manufacture should ascertain by testing that the release of lead and/or cadmium are within FDA and state acceptable limits. Details of some of these tests are listed below

Some of the more important rules, as well as the test procedures, are as follows:

7.5.1.4a LEACHABILITY OF LEAD AND CADMIUM FOR GLAZED CERAMIC SURFACES

FDA has established maximum levels for leachable lead in ceramicware, and pieces that exceed these levels are subject to recall or other agency enforcement action. The Division of Compliance Programs of the Food and Drug Administration interprets the regulations for food additives, which covers the leachability of lead and cadmium for glazed ceramic surfaces, by use of the Standard Method of Test, ASTM-C738-72 . Limits of lead range from 0.5 ppm for mugs to 3 ppm for plates and flatware. See 21 CFR 109.16 for further guidance regarding cadmium and lead in ceramics.

This specification has been adopted by the British Standards Institution and is known as the British Hot Test. This is basically the same type of procedure outlined in Exhibit D.1 except that it is done with hot acetic acid solutions rather than cold solutions. See Exhibit D page 80

This rule covers allowable limits of lead-containing paint of .06% by weight. The intent of this regulation is to control those products that may have coated surfaces with a lead content that could be injurious to children if same were ingested. While this rule is not fully applicable to metal cookware, the industry, to the best of our knowledge, generally does not apply any finish to the food contact surface of metal cookware or bakeware that would exceed allowable limits. The regulation is contained in 16 CFR-1303.

Exhibit C: ASTM Standard Method of Test for Lead and Cadmium Extracted From Glazed Ceramic Surfaces. See page

Exhibit C ASTM Standard Method of Test for Lead and Cadmium Extracted From Glazed Ceramic Surfaces. See page

7.8 POLYETHYLENE BAG MARKING

Polyethylene bags are typically used in packaging of cookware and bakeware in order to prevent cosmetic damage during shipment or while on retail display. Manufacturers should consult with polyethylene bag fabricators to make certain such bags comply with applicable regulations for warning markings in force at the time of the cookware or bakeware’s manufacture.

7.9 ENCAPSULATED AND BRAZED BOTTOM TESTING

Manufacturers are urged to test encapsulated and brazed bottoms by the use of a dry boil test. Place the pan, empty, on an appropriately sized electric burner. For pans greater than 9 inches in diameter, choose an electric resistance burner that approximates the size of a large standard U.S. range top burner. For pans less than 9 inches in diameter, choose a standard small U.S. range top burner. The electric burner is set to high and the pan is allowed to remain on the eye for ten minutes or five minutes for pans of a 1-1/2 quart capacity or smaller. Upon removal from the burner there should be no separation of the base from the body of the pan and no molten metal escaping from the body/base juncture.

1 FDA regulations governing indirect food additives can be found in 21 CFR Subchapter B; Those for resinous and polymeric coatings in 21 CFR 175.300; those for Perfluorocarbon resins in 21 CFR 177.1550; those for Colorants in Polymers in 21 CFR 178.3297. Additional sections of 21 CFR that may be applicable include, but are not limited to, Polyarylsulfone resins, 177.1560; Polyetherimide resins, 177.1595; Polysulfone resins, 177.1655; Polyethersulfone resins, 177.2440; Polyamide-imide resins, 177.2450; Polyphenylene sufide resins, 177.2490. Title 21 may be purchased at any U.S. Government Printing Office store. It is also available online at www.nara.gov/fedreg.